Back to resultsMechanism and Efficacy of Rehabilitation Approaches
Primary Purpose
Cerebrovascular Accidents
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Constraint-induced therapy (CIT)
Bilateral arm training (BAT)
Combined therapy (CT)
Control intervention
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accidents focused on measuring stroke rehabilitation, cortical reorganization, kinematic analysis
Eligibility Criteria
Inclusion Criteria:
- a first-ever clinical cerebrovascular accident patients
- at least 6 months post-stroke onset
- premorbid right-hand dominance
- demonstration of Brunnstrom stage III of the affected upper extremity
- no excessive spasticity in the joints of the affected upper extremity
Exclusion Criteria:
- a score of less than 24 on the Mini Mental State Exam
- poor physical conditions that would interfere with participation
- excessive pain in any joint that might limit participation
Sites / Locations
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Control intervention
Arm Description
constraint-induced therapy
bilateral arm training
combined therapy
Outcomes
Primary Outcome Measures
Cortical reorganization and kinematic analysis
Secondary Outcome Measures
clinical measures at the impairment, activity, participation levels
Full Information
NCT ID
NCT00564005
First Posted
November 25, 2007
Last Updated
February 10, 2015
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan, National Health Research Institutes, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT00564005
Brief Title
Mechanism and Efficacy of Rehabilitation Approaches
Official Title
Mechanisms and Long-term Effects of Separate vs. Coupled Rehabilitation Approaches After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan, National Health Research Institutes, Taiwan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Identify the possible mechanisms and the relative effectiveness of existing rehabilitation approaches that target upper extremity deficits of stroke patients on the ground that these approaches are based on neuroplasticity principles and sound motor control theories.
Detailed Description
Comparisons of constraint-induced therapy (CIT) vs. bilateral arm training (BIT)vs. combined therapy were made. Stroke patients will receive one of these three approaches and be evaluated pre- and post-treatment. the treatment will last 3 weeks and 5 days per week. The evaluation will include clinical measures of motor function, ADL, and quality of life, kinematic performance, and activation patterns of cortex.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accidents
Keywords
stroke rehabilitation, cortical reorganization, kinematic analysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
constraint-induced therapy
Arm Title
2
Arm Type
Experimental
Arm Description
bilateral arm training
Arm Title
3
Arm Type
Experimental
Arm Description
combined therapy
Arm Title
Control intervention
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Constraint-induced therapy (CIT)
Intervention Description
restraint of the unaffected arm and practice of the affected arm
Intervention Type
Other
Intervention Name(s)
Bilateral arm training (BAT)
Intervention Description
bilateral symmetric, repetitive arm training
Intervention Type
Other
Intervention Name(s)
Combined therapy (CT)
Intervention Description
combined different treatment approaches
Intervention Type
Behavioral
Intervention Name(s)
Control intervention
Intervention Description
Conventional treatment program
Primary Outcome Measure Information:
Title
Cortical reorganization and kinematic analysis
Time Frame
2008-2010
Secondary Outcome Measure Information:
Title
clinical measures at the impairment, activity, participation levels
Time Frame
2008-2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a first-ever clinical cerebrovascular accident patients
at least 6 months post-stroke onset
premorbid right-hand dominance
demonstration of Brunnstrom stage III of the affected upper extremity
no excessive spasticity in the joints of the affected upper extremity
Exclusion Criteria:
a score of less than 24 on the Mini Mental State Exam
poor physical conditions that would interfere with participation
excessive pain in any joint that might limit participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-yi Wu, ScD
Organizational Affiliation
Department of Occupational Therapy, Chang Gung Univ.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kwei-shan
State/Province
Toayuan county
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22228607
Citation
Wu CY, Chen YA, Lin KC, Chao CP, Chen YT. Constraint-induced therapy with trunk restraint for improving functional outcomes and trunk-arm control after stroke: a randomized controlled trial. Phys Ther. 2012 Apr;92(4):483-92. doi: 10.2522/ptj.20110213. Epub 2012 Jan 6.
Results Reference
derived
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Mechanism and Efficacy of Rehabilitation Approaches
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